SHR ‐2004, a Humanized Monoclonal Antibody Targeting Factor XI , for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active‐Controlled Phase 2 Study
Randomized trial demonstrates lower thromboembolism rates with twice-monthly SHR-2004 after ovarian cancer surgery, indicating a viable alternative to daily anticoagulation.
Key Points
To evaluate the efficacy and safety of SHR-2004, an anti-factor XI monoclonal antibody, compared with an enoxaparin-rivaroxaban regimen for preventing postoperative venous thromboembolism in patients undergoing ovarian cancer surgery.
Multicenter, open-label, randomized phase 2 trial conducted across 25 sites in China (NCT06220123) enrolling patients with newly diagnosed stage III-IV or recurrent ovarian cancer scheduled for surgery.
Patients were randomized (1:1) to receive subcutaneous SHR-2004 (180 mg Day 1, 120 mg Day 15; n=90 treated) or standard anticoagulation (subcutaneous enoxaparin 40 mg daily in hospital, then oral rivaroxaban 10 mg daily through Day 28; n=108 treated).
Among 181 patients completing mandatory ultrasonography, venous thromboembolism occurred in 12.6% (11/87) in the SHR-2004 group versus 20.2% (19/94) in the enoxaparin-rivaroxaban group (risk difference -8.4%, 95% CI -19.9% to 3.1%) by Day 28.
Major or clinically relevant nonmajor bleeding occurred in 2.2% (2/90) of patients receiving SHR-2004 and 1.9% (2/108) of patients receiving enoxaparin-rivaroxaban.